MRI-compatible biopsy robot

Abstract

Disclosed herein is a robotic system usable for needle-guided diagnostics. The diagnostics may include biopsies. Such a robot may be configured for use with MRI equipment, including, for example, a low-field-intensity MRI scanner. Such a robot may be of a size that is accessible inside a closed-bore tunnel type scanner.

Description

Technical Field

[0001] Cross-reference This application claims the benefit of U.S. Provisional Application No. 63 / 462,916, filed Apr. 28, 2023, the disclosure of which is incorporated herein by reference in its entirety.

Background Art

[0002] Biopsies may be used to obtain samples from a subject for testing, such as cancer testing. Biopsies can be dependent on manual needle insertion by a radiologist. Imaging techniques, such as magnetic resonance imaging (MRI), may be applied to identify the location of a lesion prior to an intervention.

Summary of the Invention

[0003] In one aspect, a biopsy robotic system is disclosed. The biopsy robotic system includes (a) a needle holder configured to insert a biopsy needle into a subject, (b) a linear mechanism configured to position the needle holder inside a magnetic resonance scanner bore, and (c) a parallel manipulator configured to orient or position the linear mechanism.

[0004] In some embodiments, the biopsy robotic system further includes a robotic cart configured to house components (a)-(c).

[0005] In some embodiments, the robotic cart is configured to be attached to or fixed to an MRI scanner.

[0006] In some embodiments, the biopsy robotic system further includes at least one optical sensor disposed behind the needle holder and configured to position the needle.

[0007] In some embodiments, at least one optical sensor is configured to confirm the accuracy of needle cocking and firing.

[0008] In some embodiments, the parallel manipulator is fixed inside the magnetic resonance scanner bore.

[0009] In some embodiments, the parallel manipulator achieves at least three degrees of freedom.

[0010] In some embodiments, the parallel manipulator is configured to connect the end effector to the base using multiple parallel kinematic chains.

[0011] In some embodiments, the needle holder has at least one degree of freedom.

[0012] In some embodiments, the biopsy robot system has at least four degrees of freedom.

[0013] Further aspects and advantages of this disclosure will be readily apparent to those skilled in the art from the following detailed description, and only exemplary embodiments of this disclosure are shown and described. As will be understood, this disclosure is adaptable to other embodiments and different embodiments, and some of its details can be modified in various obvious ways without departing from this disclosure. Accordingly, the drawings and description should be considered exemplary in nature and not limiting.

[0014] Embedding by reference All publications, patents, and patent applications described herein are incorporated herein by reference to the same extent as each individual publication, patent, or patent application is specifically and individually incorporated herein by reference. [Brief explanation of the drawing]

[0015] The novel features of the present disclosure are defined particularly in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description which sets forth exemplary embodiments. In the exemplary embodiments, the principles of the present disclosure are utilized, and the accompanying drawings (referred to herein as "Figure" and "FIG.") are as follows.

[0016] [Figure 1] An isometric view of an exemplary robotic system according to some embodiments.

[0017] [Figure 2] A top view of an exemplary robotic system according to some embodiments.

[0018] [Figure 3] An isometric view of an exemplary manipulator according to some embodiments.

[0019] [Figure 4] A schematic top view of an exemplary manipulator according to some embodiments.

[0020] [Figure 5] A top view of an exemplary manipulator and an exemplary needle holder in a random configuration, not in the home position, according to some embodiments.

[0021] [Figure 6] A side view of an exemplary needle holder when in the home position (top), and when the needle is advanced for insertion (bottom), according to embodiments described herein.

[0022] [Figure 7] A side view and a front view of an exemplary hexagonal socket end of a lead screw within a needle holder, according to embodiments described herein.

[0023] [Figure 8]Side view of an automatic firing mechanism according to some embodiments.

[0024] [Figure 9] Exemplary isometric view of an exemplary robot alongside a low-field MRI system according to some embodiments.

[0025] [Figure 10] Isometric view of an exemplary manipulator and needle holder inside a low-field MRI system, and an exemplary sample collection mechanism at the front, according to some embodiments.

[0026] [Figure 11] Isometric view showing an exemplary usage of the system according to some embodiments.

[0027] [Figure 12] Enlarged isometric view of an exemplary system during prostate biopsy according to some embodiments.

[0028] [Figure 13] Isometric view of an exemplary stand-alone configuration of an exemplary manipulator and needle holder according to some embodiments.

[0029] [Figure 14] Side view of an exemplary stand-alone configuration of an exemplary manipulator and needle holder according to some embodiments.

[0030] [Figure 15] Diagram showing a stand-alone configuration of an exemplary sample collection mechanism attached to an exemplary MRI scanner dish according to the embodiments described herein.

Best Mode for Carrying Out the Invention

[0031] This disclosure relates to a medical device, and more specifically, to a robotic arm made of safety material for medical imaging that can be used for needle-guided intervention.

[0032] Prior to intervention, imaging techniques such as magnetic resonance imaging (MRI) can be applied to locate the lesion, and the needle can be guided using imaging feedback. Biopsies may rely on manual needle insertion by a radiologist, and due to insufficient physician control of the patient within the MR scanner bore, repeated alignment and imaging may be required, potentially increasing patient risk. In contrast, robotic techniques can offer greater stiffness and precision through a more stable robotic manipulator than a human hand. The robotic manipulator can more accurately assist in the withdrawal of the needle containing the tissue sample. In some cases, robust remote operating systems and instrumentation platforms can be used for robotic MRI-guided percutaneous needle insertion. In some cases, semi-automated robotic systems have performed effective needle navigation with an error of 0.89 ± 0.31 mm in MRI-guided percutaneous needle manipulation. In some cases, robotic systems can be used for transperitoneal prostate biopsies directly guided by MRI.

[0033] Imaging-guided biopsy robots represent a technological advancement in medical interventions, aiming to improve clinical outcomes through more accurate and targeted selection, reduced invasiveness, lower procedural infections, and more effective procedures. These robots can guide the biopsy needle to the target tissue through medical imaging-based feedback. Using MRI-guided biopsy robots reduces procedure time by eliminating the need to move the patient out of the bore for intervention and back in for imaging due to insufficient space available for the procedure. This eliminates the time-consuming patient repositioning process and allows intervention and imaging to be performed simultaneously. Furthermore, manual interventions in closed bore scanners can be difficult, and sometimes impossible, due to spatial constraints inside the MRI bore, but MRI-guided biopsy robots can improve ergonomics by reducing the difficulties associated with manual interventions in closed bore scanners.

[0034] There are two main groups of biopsy robots: systems in which needle insertion is manually controlled, and systems in which needle insertion is automated. In the first group, the robot controls the position of the needle guide, and the clinician can manually insert the needle into the body. In the second group, the needle guide may be robotically positioned, and the robot can insert the needle into the body. This disclosure aims to develop a fully automated biopsy system in which the robot can control needle guidance, insertion, and sampling of multiple tissues.

[0035] Due to the high cost of high-flux-density magnets, spatial requirements, and ease of access to imaging modalities, there is growing interest in using low-field MRI scanners. Even if the image quality from low-field MRI scanners is not as high as that produced by high-field MRI scanners, diagnostically useful information can still be provided. The disclosed system can provide a novel robot for MRI-guided interventions that is compatible with various types of MRI scanners, particularly low-field scanners with small bores.

[0036] In summary, the advantages offered by image-guided biopsy robots include more accurate and less invasive procedures, reduced procedure time, improved ergonomics, and increased access to medical interventions for patients in developing countries. Fully automating biopsy procedures and developing robots compatible with various MRI scanners could be a promising solution for biopsy interventions.

[0037] This disclosure features a robotic system that may be used for needle-guided diagnostics. Such a medical device may include, but is not limited to, percutaneous interventions such as biopsy or thermotherapy. In some embodiments, such a robot may be configured for use with MRI equipment, including, for example, a low-field-intensity MRI scanner. Such a robot may be of a size that is accessible inside a closed-bore tunnel-shaped scanner. The robotic system may be capable of collecting and storing multiple samples. The robot may be constructed of materials suitable for the MRI-related working environment, such as plastics (e.g., thermoplastic polymers such as polyvinyl chloride (PVC) or polyethylene terephthalate (PET)), ceramics, non-magnetic and dielectric materials such as rubber, or any combination thereof. The robot may be used in at least two different configurations. In a first configuration, the robot may include a cart with linear guides that moves the robot inside the MRI scanner bore. In a second configuration, the robot may be fixed inside the MRI bore.

[0038] Setting the structure and workspace of a biopsy robot can be crucial to ensuring the accuracy and effectiveness of biopsy procedures. While series manipulators can offer greater workspace and more degrees of freedom, designing them to achieve sufficient rigidity and strength can be challenging, significantly impacting biopsy accuracy. In contrast, parallel manipulators are often preferred for biopsy robots due to their precise positioning and the ability to be designed to achieve high rigidity and accuracy. This is because parallel manipulators improve rigidity and accuracy by utilizing multiple parallel links to connect end effectors to the base.

[0039] The disclosed biopsy robot may be a robot-controlled driven needle guide with four or more degrees of freedom (DOF), and a needle driver with one DOF. The biopsy robot 100 may comprise three or more main parts (Figure 1). The first main part is a robot cart 110, which may have a linear mechanism 106 at its top for guiding the robot inside the MRI scanner. The second part may be a manipulator 102 for orienting the needle guide. The manipulator is insertable into a cartridge 104 of the biopsy robot 100. The third part may be a needle driver 108 for collecting tissue samples by inserting and ejecting the biopsy needle.

[0040] In the first configuration, a linear mechanism can drive the robot 100 inside the bore (Figure 11). A robot cart, equipped with a needle and its holder 1102, can be attached to and fixed to the MRI scanner 900. The developed robot system 100 is shown for MRI-guided prostate biopsy procedures. Part of the scanner 900 has been cut out for clarity. In the second configuration, the robot cart may be removed and the manipulator fixed inside the MRI bore (Figure 13). The second part may be a parallel manipulator 192 having three or more degrees of freedom, as shown in Figure 3, where the base platform of the parallel manipulator 192 can be connected to the needle holder by three or more parallel identical kinematic chains 304. The manipulator may comprise a base 301, three or more identical kinematic chains 304, and an end effector 306. The end effector 306 and the manipulator 102 may be considered in their home position when they are parallel to the base 301. The base can be fitted inside the scanner bore and designed to match the shape of the bore. The end effector 306 can be parallel to the base when three or more proximal arms rotate and each moves in front of one home positioning sensor 308.

[0041] The top cover of the manipulator may be removed to allow access to the system's internal components. As shown in Figure 4, on each kinematic chain, at least one fixed-acting rotary joint 320 and two or more free-rotating joints 326 can connect the proximal arm 322 and the distal arm 324 to the end effector 306. Three or more free-rotating joints 326 can connect the distal arm 324 to the end effector 306. Three or more high-torque, high-resolution rotary motors can actuate the proximal arm 322 on the base. This manipulator 102 can achieve three rotational depths of field (DOF): roll, pitch, and yaw.

[0042] One of the key features of this parallel manipulator is that the axes of rotation of all joints intersect at a common point called the geometric center 310 of the manipulator (Figure 3). The geometric center 310 is the point around which all elements of the needle holder rotate. In other words, the location of this point cannot change relative to the base of the manipulator.

[0043] Another feature of robot 100 is that the manipulator base 301 may include four or more collinear actuators (Figures 2 and 4). The top covers of the manipulator 102 and needle holder in robot system 100 may be removed to allow visibility into the system's interior. Three or more high-torque, high-resolution pneumatic stepper motors 112 can orient the needle holder. One or more pneumatic stepper motors 112 can insert the needle into the target lesion. Figure 4 further shows an air intake 314 that may be used to cool the system.

[0044] Figure 5 shows top views of the manipulator and needle holder in random configurations, not in their home positions, according to several embodiments. As shown, many elements of the end effector may be rotated around the robot's geometric center 310. The needle holder may have a cover to reduce cross-contamination.

[0045] The shaft that transmits motion from the actuator to the kinematic chain can be designed to be hollow to realize a collinear actuator configuration. The central axis of the actuator may also be designed to be hollow. By extending the output of the fourth actuator to the geometric center, rotational motion can be transmitted to the needle holder. Since the needle holder can rotate around the roll, pitch, and yaw axes, the round-headed hexagonal wrench mechanism 312 can be designed to transmit rotation to the lead screw. The mechanism may have a hexagonal shape at one end (Figure 3) and may be equipped with a cylindrical tool that fits into the socket of the lead screw 602 (Figure 7).

[0046] The automatic needle holder 108 can insert the biopsy needle to the target lesion in the patient's body (Figures 6 and 8). The lid 604 of the needle holder may be open to allow visibility of the interior. The needle holder may comprise a lead screw 602, a nut, and two linear pneumatic actuators. The mechanism of the lead screw 602 and nut allows for precise driving of the needle. A thread may be provided inside a portion of the needle holder 108 to match the thread of the lead screw at location 608. Furthermore, there is a hexagonal socket 606 that matches the hexagonal head of the lead screw 602. Additionally, an optical sensor 316 (Figure 4) for home positioning of the needle may be provided on the end effector at the rear of the needle holder. The mechanism of the lead screw 602 and nut can be a mechanism that converts rotational motion into precise linear motion. As the lead screw 602 rotates, the nut moves along the screw, allowing the needle to advance. More than two pneumatic actuators may be used to trigger the biopsy needle. One pneumatic actuator may be attached to the internal stylet, and a second pneumatic actuator may be connected to the cutting cannula. As shown in Figure 8, after reaching the target lesion, the first linear pneumatic actuator (upper) advances the internal stylet, and then the second pneumatic actuator (lower) presses the cutting cannula against the internal stylet to collect a sample. The sample can be extracted by the retraction of the needle. There may be separate air intakes for the two pneumatic actuators. The needle holder 108 may have an air intake for the first linear pneumatic actuator 610 and an air intake for the second linear pneumatic actuator 612. There are two sets of optical sensors 316 (Figure 4) that can be used to confirm accurate needle cocking and firing.

[0047] Figure 9 is an isometric view showing that the robot 100 can be attached to the low-field MRI scanner 900.

[0048] The sample trays in Figures 10 and 15 can be moved horizontally in two directions to fit the sample position on the tray grid, and vertically in two directions to adjust the height of the tray so that tissue is deposited on the sample needle. A small camera 1502 is mounted on the front dish to enable live monitoring of the patient and the sample tray.

[0049] Figure 10 shows isometric views of the manipulator and needle holder located inside the low-field MRI system 900, as well as the front sample collection mechanism, according to several embodiments. The shape of the manipulator can be the same as the bore so that the manipulator can move easily within the bore. The manipulator may also be fixed inside the bore. Sample collection has a tray into which the sample can be deposited. The tray can be moved up, down, left, and / or right so that it is in front of the robotic arm.

[0050] Figure 15 shows the standalone configuration of the sample collection mechanism 1500 mounted on an MRI scanner dish. A precision actuator allows the deposit tray 1504 to move from left to right or vice versa to collect tissue samples from the biopsy needle. The tray is equipped with an adjustable tray height mechanism 1506 that can move up and / or down to adjust the tray height. A miniature camera 1502 can record, monitor, and output the tissue sampling status.

[0051] Figures 11-14 illustrate the patient's position relative to the low-field MRI and robot. Figure 11 shows an isometric view of the biopsy robot 100, including the needle and its holder 1102, the MRI scanner 900, and the subject. Figure 13 shows an isometric view of the needle and its holder 1102 and the MRI scanner 900.

[0052] Figure 12 shows an enlarged isometric view illustrating an exemplary system during prostate biopsy according to several embodiments. Linear actuators on the robotic cart can guide the manipulator to a location close to the patient. The robotic cart may be equipped with a needle and its holder 1102. The manipulator can orient the needle holder. The needle can then be inserted into the target lesion. Part of the scanner may be cropped for better visibility.

[0053] Figure 14 is a side view of a standalone configuration of a manipulator, needle holder, needle holder 1102, and MRI scanner 900 according to several embodiments. The manipulator can also be fixed inside the MRI bore and operated from there. Part of the scanner 900 may be cropped for better visibility.

[0054] The base of the manipulator may be designed in various shapes and sizes so as to fit inside the scanner bore or be mounted on the patient bed. A bundle of tubes, optical fibers, pneumatic distributors, electrical circuits, a robot controller, or any combination thereof may be used to drive the robot. The device may be positioned far away from the magnetic field. The device can be designed to be positioned within the MRI system environment so as not to interfere with the MRI system's main magnetic field (B0), gradient magnetic field, or radio frequency (RF) magnetic field, particularly within the target imaging area. The device can operate reliably in the MRI system environment and is not affected by the MRI system's main magnetic field (B0), gradient magnetic field, or RF magnetic field.

[0055] definition Unless otherwise defined, all technical terms, expressions, and other technical and scientific terms or terminology used herein are intended to have the same meaning as commonly understood by those skilled in the art to which the claimed subject matter pertains. In some cases, terms having a commonly understood meaning are defined herein for clarity and / or for easy reference, and the inclusion of such definitions herein should not necessarily be interpreted as representing a substantial difference beyond what is commonly understood in the art.

[0056] Throughout this application, various embodiments may be presented in scope form. It should be understood that scope form descriptions are merely for convenience and conciseness and should not be interpreted as inflexible limitations on the scope of this disclosure. Therefore, a scope description should be considered to encompass not only the individual numerical values ​​within that scope but also all specifically disclosed feasible sub-scopes. For example, a scope description such as 1 to 6 should be considered to encompass not only the individual numerical values ​​within that scope, such as 1, 2, 3, 4, 5, and 6, but also the specifically disclosed sub-scopes such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, and 3 to 6. This applies regardless of the breadth of the scope.

[0057] The scope disclosed herein further includes any and all of the overlapping portions, sub-ranges, and combinations thereof. Phrases such as “up to,” “at least,” “greater than,” “less than,” and “between” include the stated figures. Figures preceded by terms such as “approximately,” “about,” and “nearly” as used herein include the stated figures and further represent a quantity close to the mentioned quantity that performs the desired function or achieves the desired result. The terms “about” or “approximately” may mean that a particular value is within an acceptable margin of error, and the acceptable margin of error will depend in part on how that value is measured or determined, for example, the limits of the measuring system. For example, the terms “approximately,” “about,” and “nearly” may refer to quantities that are less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the mentioned quantity. For example, “about” may mean within or greater than one standard deviation according to practice in the art. Alternatively, “approximately” may mean a range of up to 20%, 10%, 5%, or 1% of a given value. Where used herein, the term “approximately” a number refers to that number plus or minus 10% of it. The term “approximately” a range refers to that range minus 10% of its lowest value and that range plus 10% of its highest value. Where a particular value is described in this application and claims, unless otherwise stated, the term “approximately” can be assumed to mean that it is within an acceptable margin of error for that particular number.

[0058] As used herein and in the claims, the singular forms “a,” “an,” and “the” include multiple references unless the context clearly indicates otherwise. For example, the term “a sample” includes multiple samples, as well as mixtures thereof.

[0059] The terms “determining,” “measuring,” “evaluating,” “assessing,” “analyzing,” and “analyzing” are often used interchangeably herein to refer to forms of measurement. These terms include determining whether an element exists or not (e.g., detection). These terms may include quantitative, qualitative, or both quantitative and qualitative determinations. Assessment can be relative or absolute. “Detecting the presence” may, depending on the context, include determining the quantity of something that exists, in addition to determining whether something exists or not.

[0060] The terms “subject,” “individual,” or “patient” are often used interchangeably herein. “Subject” may be a biological entity containing expressed genetic material. A biological entity may be a plant, an animal, or a microorganism, such as bacteria, viruses, fungi, and protozoa. A subject may be a tissue, cell, or offspring of a biological entity obtained in vivo or cultured in vitro. A subject may be a mammal. A mammal may be a human. A subject may be diagnosed or suspected of being at high risk for a disease. In some cases, a subject may not necessarily be diagnosed or suspected of being at high risk for a disease.

[0061] Section headings used herein are for organizational purposes only and should not be construed as limiting the subject matter described herein.

[0062] While preferred embodiments of the present disclosure have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided merely as examples. Many variations, alterations, and substitutions will now be conceivable to those skilled in the art without departing from the present disclosure. It will be understood that various alternative forms to the embodiments of the present disclosure described herein may be adopted in practice. The following claims define the scope of the invention, and methods and structures within the scope of these claims and their equivalents are intended to be covered thereby.

Claims

1. (a) A needle holder configured to insert a biopsy needle into the subject, (b) A linear mechanism configured to position the needle holder inside the magnetic resonance scanner bore, (c) A biopsy robot system comprising a parallel manipulator configured to orient or position the linear mechanism.

2. The biopsy robot system according to claim 1, further comprising a robot cart configured to house components (a) to (c).

3. The biopsy robot system according to claim 2, wherein the robot cart is configured to be attached to or fixed to an MRI scanner.

4. The biopsy robot system according to any one of claims 1 to 3, further comprising at least one optical sensor positioned behind the needle holder and configured to position the needle.

5. The biopsy robot system according to claim 4, wherein the at least one optical sensor is configured to confirm the accuracy of the cocking and firing of the needle.

6. The biopsy robot system according to any one of claims 1 to 5, wherein the parallel manipulator is fixed inside the magnetic resonance scanner bore.

7. The biopsy robot system according to any one of claims 1 to 6, wherein the parallel manipulator realizes at least three degrees of freedom.

8. The biopsy robot system according to any one of claims 1 to 7, wherein the parallel manipulator is configured to connect an end effector to the base using a plurality of parallel kinematic chains.

9. The biopsy robot system according to any one of claims 1 to 8, wherein the needle holder has at least one degree of freedom.

10. The biopsy robot system according to any one of claims 1 to 9, wherein the biopsy robot system has at least four degrees of freedom.

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